Evaluation of the effect and safety of herbal extracts anti dandruff formulation comparing with clotrimazole lotion in patients with seborrheic dermatitis referring to the clinic of center for research and training in skin diseases and leprosy during the year 1394
In this randomized double blind phase 2 clinical trial control study with placebo, the efficacy and safety of anti-dandruff formulation containing herbal extracts comparing with clotrimazole lotion in patients with seborrheic dermatitis will evaluated. 20 young men aged 20-30 years, referred to dermatology clinic of Center For Research And Training In Skin Diseases And Leprosy, with clinically diagnosed seborrheic dermatitis by dermatologist, with negative history of consumption of topical antifungals and topical steroids during the last 2 weeks, and without any comorbidities such as AIDS and parkinson disease,.... will enrolled in our study. Patients randomly divided into two groups, after signing the consent form. The first group will use anti-dandruff formulation containing herbal extracts and the second group will use clotrimazole lotion. They use the lotions twice a day for 4 weeks. Dandruff severity, amount of scalp sebum and scalp PH evaluated before treatment, 2 weeks and 4 weeks after treatments and then the data will analysis.
The amount of scalp sebum will evaluated by the sebometer.
The PHmeter will used for evaluating the scalp PH.
Dandruffmeter will used for analyzing the size and severity of dandruff.
For comparing the effect of herbal extract formulation with clotrimazole lotion, the results of scalp PH, sebum secretion and size and severity of scalp dandruff will analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012520802N1
Registration date:2015-08-15, 1394/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-15, 1394/05/24
Registrant information
Name
Hamid reza Ahmadi Ashtiani
Name of organization / entity
Islamic Azad university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2278 2576
Email address
ahmadi@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Islamic Azad University Pharmaceutical Branch of Tehran
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect and safety of herbal extracts anti dandruff formulation comparing with clotrimazole lotion in patients with seborrheic dermatitis referring to the clinic of center for research and training in skin diseases and leprosy during the year 1394
Public title
Herbal extract solution in treatment of seborrheic dermatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
male patients; healthy general condition; clinically diagnosed seborrheic dermatitis; 20-30 years old; consent form signed by patients.
Exclusion criteria:
use of topical steroids during 2 weeks ago; use of topical retinoids during 2 weeks ago; use of topical antifungals during 2 weeks ago; use oftopical anti-inflammatory druds during 2 weeks ago; use of topical antibiotics and any other topical treatments for seborrheic dermatitis like anti-dandruff shampoo and coal tar during 2 weeks ago; use of systemic anti-fungals during the last month; use of systemic steroids during the last month; use of systemic antibiotic during the last month; use of systemic anti-inflammatory drugs and immunomodulator drugs during the last month; use oral retinoid during last 6 months; history of hypersensitivity to azoles or herbal compound of our solution; comorbidities(AIDS,Parkinson,diabetes,…); skin disease like psoriasis, acne, …
Age
From 20 years old to 30 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of centre for research and training in skin disease and leprosy
Street address
415,Taleghani st
City
Tehran
Postal code
Approval date
2015-04-18, 1394/01/29
Ethics committee reference number
27533
Health conditions studied
1
Description of health condition studied
Seborrheic Dermatitis
ICD-10 code
L21.8
ICD-10 code description
Other seborrhoeic dermatitis
Primary outcomes
1
Description
Scalp sebum
Timepoint
Beginning of the study, 2 weeks and 4 weeks after starting the treatment
Method of measurement
Sebometer
2
Description
Scalp PH
Timepoint
Beginning of the study, 2 weeks and 4 weeks after starting the treatment
Method of measurement
PH meter
3
Description
Dandruff
Timepoint
Beginning of the study, 2 weeks and 4 weeks after starting the treatment
Method of measurement
Pixel
Secondary outcomes
1
Description
Erythema and itching
Timepoint
Begining of the study,2 weeks and 4 weeks after treatment
Method of measurement
Clinical examination, Questionnaire
Intervention groups
1
Description
Volunteers in the intervention group use the anti dandruff lotion with herbal extracts twice a day for 4 weeks,1 cc per consumption topical on their scalp
Category
Treatment - Drugs
2
Description
Volunteers in the control group use clotrimazole lotion 1 cc twice daily for 4 weeks, topically on their scalp
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center For Research and Training in Skin Diseases and Leprosy
Full name of responsible person
Dr. Azin Ayatollahi
Street address
415, Taleghani street, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Islamic Azad University Pharmaceutical Branch of Tehran
Full name of responsible person
Dr Afsaneh Arbabi
Street address
Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal st, Shariati Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Islamic Azad University Pharmaceutical Branch of Tehran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences Branch of Islamic Azad University
Full name of responsible person
Dr Hamid Reza Ahmadi Ashtiani
Position
Assistant Professor
Other areas of specialty/work
Street address
Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal St, Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
Email
ahmadi@iaups.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Sciences Branch of Islamic Azad University
Full name of responsible person
Dr Hamid Reza Ahmadi Ashtiani
Position
Assistant Professor
Other areas of specialty/work
Street address
Pharmaceutical Sciences Branch of Islamic Azad University, Yakhchal St, Shariati Ave.